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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K813565
Device Name RADIATION STERILIZED SURGEON'S GLOVES
Applicant
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/22/1981
Decision Date 01/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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